# C_2007183EN.01000201.xml

| 4.8.2007 | EN | Official Journal of the European Union | C 183/2 |
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4.8.2007

EN

Official Journal of the European Union

C 183/2

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Judgment of the Court (First Chamber) of 14 June 2007 (reference for a preliminary ruling from the Simvoulio tis Epikratias, Greece) — Medipac-Kazantzidis AE v Venizelio-Pananio (PE.S.Y. KRITIS)

(Case C-6/05) (1)

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(Free movement of goods - Directive 93/42/EEC - Hospital purchase of medical devices bearing the CE marking - Protective measures - Public supply contract - Contract falling below the threshold of application of Directive 93/36/EEC - Principle of equal treatment and obligation of transparency)

(2007/C 183/02)

Language of the case: Greek

Referring court

Simvoulio tis Epikratias

Parties to the main proceedings

Applicant: Medipac-Kazantzidis AE

Applicant:

Defendant: Venizelio-Pananio (PE.S.Y. KRITIS)

Defendant:

Re:

Reference for a preliminary ruling — Symvoulio tis Epikrateias — Interpretation of Council Directive 93/36/EEC of 14 June 1993 coordinating procedures for the award of public supply contracts (OJ 1993 L 199, p. 1) and Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1) — Rejection of a tender concerning products bearing the CE marking — Insufficiency of the products in terms of their quality, having regard to the protection of public health and the particular use for which they are intended — Procedure for the supply of medical devices to a hospital

Operative part of the judgment

| 1) | The principle of equal treatment and the obligation of transparency preclude a contracting authority, which has issued an invitation to tender for the supply of medical devices and specified that those devices must comply with the European Pharmacopoeia and bear the CE marking, from rejecting, directly and without following the safeguard procedure provided for in Articles 8 and 18 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003, on grounds of protection of public health, the materials proposed, if they comply with the stated technical requirement. If the contracting authority considers that those materials may jeopardise public health, it is required to inform the competent national authority with a view to setting that safeguard procedure in motion. |
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1)

The principle of equal treatment and the obligation of transparency preclude a contracting authority, which has issued an invitation to tender for the supply of medical devices and specified that those devices must comply with the European Pharmacopoeia and bear the CE marking, from rejecting, directly and without following the safeguard procedure provided for in Articles 8 and 18 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003, on grounds of protection of public health, the materials proposed, if they comply with the stated technical requirement. If the contracting authority considers that those materials may jeopardise public health, it is required to inform the competent national authority with a view to setting that safeguard procedure in motion.

| 2) | A contracting authority, which has referred a matter to the competent national authority with a view to setting in motion the safeguard procedure provided for by Articles 8 and 18 of Directive 93/42, as amended by Regulation No 1882/2003, concerning medical devices bearing the CE marking, is required to suspend the tendering procedure until the end of that safeguard procedure, the outcome of that procedure being binding on the contracting authority. If the implementation of such a safeguard procedure gives rise to delays liable to jeopardise the operation of a public hospital and thereby public health, the contracting authority is entitled to take all interim measures required to enable it to procure the materials necessary for the smooth running of that hospital, subject to compliance with the principle of proportionality. |
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2)

A contracting authority, which has referred a matter to the competent national authority with a view to setting in motion the safeguard procedure provided for by Articles 8 and 18 of Directive 93/42, as amended by Regulation No 1882/2003, concerning medical devices bearing the CE marking, is required to suspend the tendering procedure until the end of that safeguard procedure, the outcome of that procedure being binding on the contracting authority. If the implementation of such a safeguard procedure gives rise to delays liable to jeopardise the operation of a public hospital and thereby public health, the contracting authority is entitled to take all interim measures required to enable it to procure the materials necessary for the smooth running of that hospital, subject to compliance with the principle of proportionality.

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(1)  OJ C 69, 19.3.2005.

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